Evidence map›Paper›PMID 39640219›Full record

ArticleJHEP reports : innovation in hepatology2024

A home-based exercise programme attenuates fatigue in primary biliary cholangitis: Results from the EXCITED clinical trial.

Alice Freer, Felicity R Williams, Simon Durman, Jennifer Hayden, Matthew J Armstrong, Palak J Trivedi

2 registry-linked trialsAbstract read
In one paragraph

Article in JHEP reports : innovation in hepatology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04265235 naterminatednot on this map

EXerCise Intervention in cholesTatic LivEr Disease: The EXCITED Study

TypeinterventionalSponsorUniversity of BirminghamRan2019 to 2020Enrolled31ConditionsPrimary Biliary CholangitisArmsHome-based exercise program
NCT07161245 narecruitingnot on this mapstarted 2025, after this paper: background citation

A Randomized Clinical Trial on the Improvement of Fatigue in Patients With Primary Biliary Cholangitis by Implementation of a Multimodal Rehabilitation Program and Study of Its Pathophysiological Mechanisms

TypeinterventionalSponsorHospital Clinic of BarcelonaRan2025 to 2026Enrolled64ConditionsPrimary Biliary Cholangitis (PBC)ArmsMultimodal prehabilitation, standard of care
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Alice FreerNational Institute of Health Research (NIHR) Birmingham Biomedical Research Centre (BRC), Centre for Liver and Gastrointestinal Research, University of Birmingham, Birmingham, UK.
Felicity R WilliamsNational Institute of Health Research (NIHR) Birmingham Biomedical Research Centre (BRC), Centre for Liver and Gastrointestinal Research, University of Birmingham, Birmingham, UK.
Simon DurmanLiver Unit, University Hospitals Birmingham Queen Elizabeth. Birmingham UK.
Jennifer HaydenLiver Unit, University Hospitals Birmingham Queen Elizabeth. Birmingham UK.
Matthew J ArmstrongNational Institute of Health Research (NIHR) Birmingham Biomedical Research Centre (BRC), Centre for Liver and Gastrointestinal Research, University of Birmingham, Birmingham, UK.
Palak J TrivediNational Institute of Health Research (NIHR) Birmingham Biomedical Research Centre (BRC), Centre for Liver and Gastrointestinal Research, University of Birmingham, Birmingham, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background & Aims: Fatigue is a commonly reported symptom of primary biliary cholangitis (PBC). We conducted a single-arm, open-label clinical trial to assess the efficacy of a physiotherapist-led home-based exercise programme (HBEP) in patients with PBC and moderate-to-severe fatigue (NCT04265235). Methods: A 12-week individualised HBEP (aerobic + resistance based) was delivered to patients with a PBC-40 fatigue domain score ≥33. The primary efficacy outcome measure was a reduction in fatigue severity by ≥5 points. Secondary outcome measures included other domains of PBC-40, the FIS (fatigue impact scale), ESS (Epworth sleepiness score), HADS (hospital anxiety and depression scale), aerobic capacity (ISWT [incremental shuttle walk test], Duke activity status index (predicted VO₂ peak) and physical function (short physical performance battery [SPPB]). Results: A total of 31 patients were recruited, of whom 30 completed the 12-week HBEP (29 women; median age 53 years, median alkaline phosphatase value: 1.5x the upper limit of normal, median bilirubin: 12 μmol/L, and median baseline PBC-40 fatigue score 42). The primary outcome was met by 26 patients, with a median reduction in PBC-40 fatigue score of -10.5 points (IQR -9 to -13; Conclusion: This proof-of-concept study shows that a HBEP is safe, feasible, and has the potential to attenuate fatigue. Controlled trials are needed to validate the efficacy of exercise interventions in PBC. Impact and implications: Fatigue is a common symptom in primary biliary cholangitis (PBC), and is linked to cognitive dysfunction, somnolence, and reduced activity. The pathogenesis is multifactorial, and muscle bioenergetic abnormalities have been proposed to contribute. In this study, we show that a home-based exercise programme, consisting of aerobic and resistance-based sets, can be safely delivered to people living with PBC. In addition, the programme led to a reduction in fatigue severity, less daytime sleepiness and improved cognitive function.

Indexed as

Autoimmune Liver DiseaseCholestasisFunctional CapacityHealth Related Quality of LifePatient Reported Outcome MeasureSymptoms

Identifiers

PMID39640219
PMCPMC11617285

What Socratic holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.